A Phase 1 interventional study of HIVIS DNA/MVA-CMDR and HIVIS DNA + Cervarix and MVA-CMDR in HIV Infections, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. Completed at 1 site in South Africa. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine · Phase 1, Interventional, and Treatment
Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens with or without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth
HIVIS DNA and MVA-CMDR vaccines induce immune responses important for clearing infected cells: broad HIV-specific CD8+ cytotoxic T cells, potent antibodydependent cellular cytotoxicity (ADCC), and binding antibody (Ab) and neutralizing antibody (NAb). The study include early treated children because of their healthy immunity and small HIV reservoirs. Giving licensed vaccine, Cervarix®, against human papilloma virus (HPV) that contains toll-like receptor (TLR) 4 agonist with HIVIS DNA could increase DNA antigen loading on dendritic cells and promote adaptive immune responses to the HIV vaccine.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 25 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Henry M. Jackson Foundation for the Advancement of Military Medicine is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Laboratory criteria within 8 weeks prior to enrollment
Exclusion criteria:
Arm 1 (n=10) will receive 1500 micrograms (0.5ml) HIVIS DNA IM by needle-free injection at weeks 0 and 4 followed by intramuscular (IM) needle injection of 1 X 108 IU/mL (1ml) MVA-CMDR at weeks 24 and 36 in the same arm as HIVIS DNA. Participants who have been randomized to receive HIVIS DNA and MVA-CMDR alone (ARM 1) will be administered Cervarix after week 72, the last study follow-up visit, if required.
Biological: HIVIS DNA/MVA-CMDR
Arm 2 (n=10) will receive 0.5 ml of Cervarix IM by needle injection followed by 1500 micrograms (0.5ml) per injection of HIVIS DNA IM by a needle-free injection device in the skin above (proximal to) the Cervarix injection (within 1.5 cm). They will receive 1 X 108 IU/mL (1ml) MVA-CMDR IM by needle injection at weeks 24 and 36 in the same arm as HIVIS DNA. They will also receive 0.5 ml Cervarix at the time of the first MVACMDR injection in the opposite arm from the MVA injection at week 24.
Biological: HIVIS DNA + Cervarix and MVA-CMDR
Arm 3 (n=5) will receive 0.5 ml of Cervarix by IM needle injection at weeks 0, 4 and 24.
Biological: Cervarix
HIVIS DNA IM by needle-free injection at weeks 0 and 4 followed by intramuscular (IM) needle injection of 1 X 108 IU/mL (1ml) MVA-CMDR at weeks 24 and 36 in the same arm as HIVIS DNA.
Cervarix IM by needle injection followed by 1500 micrograms (0.5ml) per injection of HIVIS DNA IM by a needle-free injection device in the skin above (proximal to) the Cervarix injection (within 1.5 cm). They will receive 1 X 108 IU/mL (1ml) MVA-CMDR IM by needle injection at weeks 24 and 36 in the same arm as HIVIS DNA. They will also receive 0.5 ml Cervarix at the time of the first MVACMDR injection in the opposite arm from the MVA injection at week 24.
Cervarix by IM needle injection at weeks 0, 4 and 24.
Solicited and unsolicited serious adverse events
Safety
Time frame: through study completion, an average of 1 year
Frequencies of CD4+ T cells that produce Tat/Rev transcription (tat/rev RNA+ cells/106 CD4+ T cells)
Efficacy
Time frame: Change from Baseline at week 24, 36, 48, 60, 72
HIV DNA (copies/106 CD4+ T cells)
Efficacy
Time frame: Change from Baseline at week 28, 48
Solicited and unsolicited non-serious adverse events
Safety
Time frame: through study completion, an average of 1 year
Unspliced and multiply-spliced RNA+ cells/1000 ng cellular RNA
Efficacy
Time frame: Week 24, 36, 48, 60, 72
IUPM from total CD4+ T cells in blood by QVOA
Efficacy
Time frame: Week 24, 36, 48, 60, 72
Plasma HIV RNA by SCA
Efficacy
Time frame: Week 24, 36, 48, 60, 72
HIV-specific CD8+ and CD4+ T cells
Immunogicity
Time frame: Week 28, 48
ADCC
Immunogicity
Time frame: Week 28, 48
Binding and neutralizing Ab
Immunogicity
Time frame: Week 28, 48
Global gene expression on PBMCs by RNA seq
immune response
Time frame: Week 28, 48
Gene expression on HIV-specific CD8+ and CD4+ T cells
immune response
Time frame: Week 28, 48
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Henry M. Jackson Foundation for the Advancement of Military Medicine